Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05806463 |
| Other study ID # |
23020 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 4, 2023 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Johns Hopkins Bloomberg School of Public Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Mother's Time is an evidence-based cognitive behavioral therapy (CBT) tool designed to
support postpartum women experiencing mild to moderate symptoms of stress, depression or
anxiety. The intervention is designed for use by Ethiopian community health workers (CHWs)
and includes CBT exercises and discussion on topics relating to family planning, such as
planning for the future, speaking to the husband, and considering potential side effects.
The primary objective of this research is to test the efficacy of Mother's Time, on mild to
moderate symptoms of postpartum stress, anxiety, and depression as well as associated
behavioral and social barriers to postpartum family planning, specifically among women under
25 who have given birth within the last year.
Description:
Mother's Time is an evidence-based cognitive behavioral therapy (CBT) tool designed to
support postpartum women experiencing mild to moderate symptoms of stress, depression, or
anxiety. The intervention is designed for use by Ethiopian community health workers (CHWs)
and includes CBT exercises and discussion on topics relating to family planning, such as
planning for the future, speaking to the husband, and considering potential side effects.
The primary objective of this research is to test the efficacy of Mother's Time, on mild to
moderate symptoms of postpartum stress, anxiety, and depression as well as associated
behavioral and social barriers to postpartum family planning, specifically among women under
25 who have given birth within the last year. This study builds on evidence from a previous
study (Principal Investigator: Hendrickson, Institutional Review Board (IRB) #: 16604)
demonstrating the feasibility and acceptability of using Mother's Time to address mild to
moderate depressive and anxiety symptoms and associated behavioral and social barriers to
family planning in Ethiopia. The study also builds on previous human-centered design work
(Principal Investigator: Hendrickson, IRB #: 21414) to obtain further design input on the
Mother's Time intervention. The investigators have adapted the intervention based on data and
findings from the pilot study and the Human Centered Design workshop. The specific aims of
this study are to:
1) Quantitatively examine the impact of participating in Mother's Time on symptoms of stress,
depression, and anxiety among postpartum women ages 16-24 years of age who have given birth
within the last year.
1a) Assess the immediate (post intervention) and longer term (3-month post-intervention)
impact of participation in Mother's Time on symptoms of stress, depression, and anxiety.
2) Quantitatively assess the impact of participating in Mother's Time on use of a modern
contraceptive method among postpartum women ages 16-24 years of age who have given birth
within the last year.
2a) Assess the immediate (post intervention) and longer term (3-month post-intervention)
impact of participation in Mother's Time on use of a modern contraceptive method among
postpartum women.
2b) Quantitatively assess the impact of participating in Mother's Time on perceived benefits
and self-efficacy to engage in healthy thinking patterns and modify behaviors related to
family planning.
3) Explore feasibility and acceptability of implementing Mothers Time from the perspective of
health extension workers (HEWs) and HEW supervisors.
